IAHF
List: Please See Byron Richard's latest update on
the S.1082 below. Thanks for your ongoing assistance-
please keep making calls and sending faxes and emails
today. The Senate is out of session today, but staff are still
there for you to communicate with.

An IAHF
ally on Capital Hill is making a concerted effort to try to persuade
Senator Tom Coburn of Oklahoma to introduce the
Emord amendment (our amendment to remove the terms "Foods and
Food Ingredients") to the bill. Senator Coburn is an MD and
he is in the dietary supplement caucus. He values alternative medicine
and dietary supplements and has expressed the view that the high cost of
health care could be reduced if more people were to utilize dietary
supplements for preventive purposes.

I am
going to need to travel to DC at some point when this
legislation gets into the House, but its too soon to tell when that
will be. Please keep in mind that the Senate and House language ends up
being cojoined via whats called a
"Conference Report" and that
COMBINED PACKAGE is what gets sent
to the President's desk for his signature. (All kinds of mischief
often happens when the combine the House and Senate language into one
package.) The price of freedom is
eternal vigilance. Donations for airfare and 10 days lodging on the
Hill to insure that we don't get burned in the House and in the
Conference Committee Markup would be very helpful at this time.

S1082 – The Voice of the People is
Being HeardThere is still time to stop FDA,
Inc.

May 5, 2007

By Byron Richards,
CCN

NewsWithViews.com

permission to reprint

Bill S1082 is a bill that
helps fund the FDA with Big Pharma money.It is known
all over Capital Hill as Big Pharma-designed legislation.It is running into all sorts of credibility problems.A vote is likely on Monday – delayed due to all the
opposition flooding the Senate by “we the people.”

Major Problem #1 –
A Fair Price for Drugs.

Realizing that meaningful
FDA reform legislation is not likely again for ten years numerous Senators
are backing the Dorgan amendment to S1082.The
amendment enables U.S. citizens to buy drugs from Canada and other
industrialized nations.This will save us at least 50
billion dollars over the next ten years and cut the price of many drugs in
half.Those opposing the amendment, which includes most
of the major proponents of S1082 and the Bush administration, are the ones
clearly on the payroll of Big Pharma.Their excuse
for not supporting it is flimsy – that it will cause safety
problems.The majority of Senators are not buying this
transparent cover-up.Dorgan won Round 1 of the voting
on his amendment yesterday (63-28), showing that he has the power to hit
Big Pharma where it hurts – in the pocketbook.A
final vote on the Dorgan amendment is expected Monday (keep up support for
the Dorgan amendment).

Major Problem #2 –
A Fake Safety Bill.

Last year’s
Institute of Medicine report labeled FDA management as dysfunctional
causing FDA reform to pick up momentum.To deflect
public outrage S1082 was created by Kennedy and Enzi, in close
consultation with the FDA and Big Pharma.As you might
expect from such a meeting of the minds, the bill is really a Big
Pharma-sponsored con job and it actually increases the power of
dysfunctional FDA management.

Unfortunately for Big
Pharma and the FDA, Charles Grassley (R-IA), a man concerned with true and
meaningful safety reform, has gone through S1082 with a fine tooth
comb.He has proposed 11
amendments to
close the Big Pharma loopholes that Kennedy, Enzi, the FDA, and Big Pharma
built into this legislation.Big Pharma and the FDA hate
all 11 Grassley amendments and Big Pharma has its legion of lobbyists
trying to defeat them as you read this.Support the
Grassley amendments for true and meaningful safety reform.

Major Problem #3 –
A Sneak Attack on Dietary Supplements.

As I have been reporting
for the last week, language relating to the Reagan-Udall Foundation for
the FDA creates a new regulatory category and broadens FDA power in a way
that can be used to attack dietary supplements.In
response to this devious threat, Jonathan Emord, our nations leading
health freedom attorney, prepared amendment language to nullify the threat
– an amendment we now call The People’s Amendment.Many of you flooded the Senate with your objections – AND
YOUR VOICE IS BEING HEARD.

I have obtained an e-mail
message from David Taylor, the president of the Natural Products
Association, which went out to various heads of nutrition companies
– in an effort to get companies not to protest S1082 (dietary
supplement trade groups are not the friends of health
freedom).It contained an attachment with a transcribed
conversation between Hatch, Harkin, Kennedy, and Enzi about all the phone
calls you’ve been making.It shows that Hatch and
Harkin don’t really understand what the Reagan-Udall foundation is,
that Kennedy and Enzi are lying about what it will do, AND THAT WE ARE
GETTING THROUGH.Here is the text:

SEN. HATCH:My office has been inundated by calls from people throughout the
country who believe that this legislation, specifically the provision
establishing a Reagan-Udall Institute, will overturn the Dietary
Supplement Health and Education Act of 1994.That has
not been my reading of the bill, but I wonder if other Senators have heard
similar concerns?

SEN. HARKIN:Yes, I have received a good many calls as well.And, I have to say that I would be very concerned, as I know the
Senator from Utah is, if anything in the bill we are considering, S. 1082,
would overturn DSHEA, a law we fought side-by-side to see enacted.

SEN. ENZI:It might be helpful if I explained the provision you are
discussing, as my office has received many calls as well and I believe the
callers are not informed about this matter.Subtitle B
of Title II of S. 1028, establishes the Reagan-Udall Foundation for the
Food and Drug Administration.That simple purpose of
that non-profit Foundation is to lead collaborations among the FDA,
academic research institutions and industry designed to bolster research
and development productivity, provide new tools for improving safety in
regulated product evaluation, and in the long-term make the development of
those products more predictable and manageable.

SEN. KENNEDY:That is exactly the purpose of the Foundation, which was included in
the drug safety legislation Senator Enzi and I introduced last
year.The Foundation will be financially supported by
industry and philanthropic donated funds.A Chief
Scientist at FDA will promote intramural research and coordinate it with
efforts at the Foundation.

SEN. HATCH.:That explanation is very helpful.What,
specifically, would the role of the Foundation be with respect to dietary
supplements?

SEN. KENNEDY:Let me make absolutely clear that the Reagan-Udall Foundation will
in no way override, overturn or conflict with the Dietary Supplement
Health and Education Act.Nothing in this bill would
have that effect.

SEN. ENZI:Yes, we took great pains to make certain there would be no conflict
with DSHEA.Regarding foods, and dietary supplements are
generally regulated as foods, the general directive of the Foundation is to
identify holes in the evaluation of food safety and identify ways to
address those deficiencies through collaborative research with
industry.

SEN. HARKIN:So, to make this absolutely clear, what you are saying is that the
bill we are debating would in no way interfere with consumers’
access to dietary supplements?

SEN. HATCH:To add to that point, it seems that the language could, in fact,
help dietary supplement consumers, because it would allow collaboration
between government and industry to conduct research on issues that might
be helpful to supplement consumers?

SEN. KENNEDY:Yes, that is the case.

SEN. ENZI:I agree with Chairman Kennedy’s assessment.

SEN. HATCH:I thank you for those assurances and that clarification.

SEN. HARKIN:This has been a very helpful discussion, because Senator Hatch and
I could never support legislation that would interfere with DSHEA and we
are glad to receive the assurances of the Chairman and the Ranking
Republican on the Committee.

This is a major
breakthrough – Kennedy and Enzi are now on record stating this will
in no way affect our dietary supplements.And Hatch and
Harkin are on record as being concerned.There are still
two problems.1)Kennedy and Enzi are
hard to trust, based on all the Big Pharma loopholes built into their
bill.2)The FDA and its lawyers get
to interpret what S1082 means once it becomes law.The
FDA could care less what Hatch, Kennedy or Enzi intended to
say.Until the language is fixed it is a
problem of magnitude.

Major Problem #4 –
The Creation of FDA, Inc.

As you can see from
the Kennedy and Enzi comments above, they are portraying the Reagan-Udall
Foundation for the FDA as a benevolent and friendly group that will
facilitate collaboration between the FDA, academia, and private industry
– receiving funding from industry and philanthropic donations
– and oh yes, let’s not forget the foundation may even help
with safety.Do you really think the FDA needs to
create a whole organization to do that?And why
wouldn’t such duties just be the function of a few people or a
department within the FDA?

It is my opinion that the
primary reason for bill S1082 is to create FDA, Inc. by using the
Reagan-Udall Foundation for the FDA.The FDA wants to
be in the drug development and marketing business and is looking for a way
to do it.Most of the issues in S1082 are a smokescreen,
keeping Senators like Grassley busy fighting all the Big Pharma
loopholes.So far Kennedy and Enzi have skillfully
created so much diversion that nobody is paying attention to the FDA
becoming a drug company.

In a nutshell,
Andrew von Eschenbach, M.D, head of the FDA, has a long history of
involvement with the cancer-for-profit industry.His
resume includes being head of the National Cancer Institute, where he
routinely diverted funding from solid cancer science into the pockets of
his friends in Big Bio Tech.He was also a lead player
in an old boy network called C-Change, a group of the most powerful vested
interests in biotechnology and cancer research – which is headed by
George Bush Sr. and his wife, Barbara.It is not
surprising that the current president backs Big Pharma and Big Biotech as
he does – his family wealth depends on it.Drug
research and development performed at the Reagan-Udall Foundation will
undoubtedly be paid for, in large part, by companies who have grants from
the National Cancer Institute (taxpayer funds).

Von Eschenbach took over
the helm of the FDA to create his dream of a cancer sickness industry
wherein nobody actually gets well – they just live indefinitely in a
sick condition on really expensive biotech drugs.This
project is called the Critical Path Initiative.The FDA
has created highly sophisticated software that can identify
protein-molecule changes at the cellular level.The FDA
wants to use this computer software to design the entire next generation of
powerful biological medicines – making all of private industry use
its software technology.The Reagan-Udall foundation is
the tool that FDA plans to use for patent protection and licensing
arrangements of its technology with private industry – and thus the
creation of FDA, Inc.Von Eschenbach is on record as
stating that the Critical Path Initiative is the FDA’s top priority
(not drug safety or food safety).

The Critical Path
Initiative has been repeatedly attacked because it would expose patients
to drugs with far less testing for safety and effectiveness compared to
drugs already on the market.Furthermore, these
biologic drugs will be far more powerful because they throw gene switches
in cells – meaning the risk for adverse events
skyrockets.Initially, just patients with no other
medical hope will be the guinea pigs.The FDA wants to
run this technology in all doctor’s offices around the country
– which will require your DNA in an FDA-owned government
database.This is not science fiction – this is
what the FDA is on public record as wanting to do.

Keep Taking Action
– Revised letter

Anti S.1082 Food
and Drug Revitalization Act

May 5, 2007

The Honorable (Senator
First and Last Name)

Address
Address

Dear Senator Last Name;

The issue of drug safety
and access to drugs at a fair price is of the utmost importance to myself
and all Americans. In general, I am opposed to Senate bill S1082: Food and
Drug Administration Revitalization Act, as it does not go far enough to
protect myself and my family from the dangers of drugs. If it is to be
passed I want all 11 Grassley amendments which are true safety reform
added to the bill.I am also in favor of the Dorgan
amendment that enables Americans to get a fair price on prescription
medication.

As one of the 150 million
Americans that rely on dietary supplements to keep myself and my family
well, I am especially concerned that this legislation broadens FDA
regulatory power to harass functional foods and dietary supplements
– which has nothing whatsoever to do with drug safety.
While Senator’s Kennedy and Enzi are
telling us not to be concerned – we simply don’t trust the FDA
and want language that protects dietary supplements in this legislation.

It is vital that the
terms “food” and “food ingredients” be removed
from this legislation. There must be no confusing the safety of drugs and
the safety of food and food ingredients – which are governed by
different laws. This bill authorizes the creation of a new regulatory
category that enables the FDA and the Reagan-Udall Foundation for the FDA
to attack dietary supplements and functional foods. This problem in the
wording can be corrected with this simple amendment – so as to be
sure this legislation is about drugs and drug safety only.

Amendment
to Bill S1082

Purpose of the
amendment:The bill, S1082:
The Food and Drug Administration Revitalization Act, is hereby amended to
eliminate any reference to the terms food or food ingredients, such that
food and food ingredients will not be subject to any jurisdiction or
control by the Reagan-Udall Foundation for the Food and Drug
Administration.

Intent of
amendment:To eliminate
from the bill any possibility that food or food ingredients would be
treated like drugs either for safety review purposes or for assessment of
their efficacy. It is a fundamental tenet of food and drug law that foods
and food ingredients are presumed to be safe and have to be established to
be adulterated only if they present a significant or unreasonable risk of
illness or injury.